Mobility: Impact of the Erigo Machine on Functional Recovery in ICU Patients

• Sponsor: Lisa J. Fryman (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02615990
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

This study will assess the effects of the Erigo applied as part of the early mobilization program in the Trauma ICU at the University of Kentucky. It is our hypothesis, that with the Erigo, critically ill patients will tolerate verticalization and mobilization earlier and safely resulting in improved outcomes measured by increased mobility and strength on ICU discharge, decreased requirements for mechanical ventilation, reduced complication rates and decreased ICU and hospital LOS.

Condition or Disease	Intervention/Treatment	Phase
Trauma Patients Requiring Physical Rehabilitation	Device: Erigo Pro; Other: Standard Physical Therapy	N/A

Detailed Description

The "Erigo" by Hocoma is a combination of tilt table with a robotic stepper device allowing for cyclic leg loading. Erigo now also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It allows for protected gradual verticalization and mobilization based on patient tolerance and progress. It has been shown to improve orthostatic tolerance, cerebral blood flow and muscle strength.

Prospective Randomized Controlled Trial will compare two groups. The patients that meet inclusion criteria will be randomized into either the treatment group or a control group. General ICU mobility guidelines consist of scaled activity related to the patients' stability. The control group will get the general ICU mobility treatments and the treatment group will have one mobility treatment replaced with the Erigo treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of the Erigo Machine on Functional Recovery in ICU
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erigo Pro plus standard Physical Therapy The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.	Device: Erigo Pro; Verticalization table with two integrated robotic devices for leg movement and cyclic loading; Other Names: Verticalization table Item #29673 Hocoma products
Active Comparator: Standard Physical Therapy Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements.	Other: Standard Physical Therapy; Patients receive standard physical therapy.

Outcome Measures

Primary Outcome Measures

1. Orthostatic Tolerance During Verticalization [Up to one year]

   Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from lying down to standing. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial verticalization after injury and at each treatment session there after until they achieve ambulation (the ability to move without assistance). Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from lying to standing.

2. Orthostatic Tolerance During Ambulation [Up to one year]

   Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from standing to full ambulation. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial unassisted standing and then during each treatment session there after until discharge. Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from standing to full ambulation.

Secondary Outcome Measures

1. ICU Length of Stay [Up to three months]

   The duration of stay in the Trauma ICU will be measured and compared between groups. Data will be presented as mean number of days in the ICU.

2. Hospital Length of Stay [Up to one year]

   The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.

3. Incidence of Pneumonia While Hospitalized [Up to one year]

   Incidence of pneumonia while hospitalized will be determined by clinical symptoms to include temperature >100.8 degrees F, WBC>12,000 WBC/mm3 , PaO2/Fio2 ratio < 300 mmHg, positive respiratory culture for organisms and chest x-ray indicative of pneumonia. Total incidence will be compared between groups and presented as a total count of pneumonia diagnoses per group.

4. Incidence of Urinary Tract Infections While Hospitalized [Up to one year]

   Incidence of urinary tract infection during hospitalization will be determined by clinical symptoms to include temperature of > 100.8 degrees F, WBC> 12000 WBC/MM3, patient complaints of pain, positive urine culture. Total incidence will be compared between groups and presented as a total count of urinary tract infection diagnoses per group.

5. Incidence of Deep Vein Thrombosis (DVT) [Up to one year]

   Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool

6. Incidence of Pressure Ulcers [Up to one year]

   Incidence of pressure ulcers determined by physical observation. Total incidence will be compared between groups and presented as a total count of pressure ulcer diagnoses per group.

7. Incidence of Physical Instability [Up to one year]

   Incidence of physical instability with be calculated as the number of falls per participant while hospitalized. Data will be presented as the number of falls per participant per group.

8. Incidence of Catheter Disruption [Up to one year]

   Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.

9. Measure of Physical Capacity [At discharge (up to 1 year)]

   Kansas University Hospital Physical Therapy Acute Care Functional Outcome Tool will be utilized to assess the participant's overall physical function prior to discharge. . Total score: 0 - 32, usually divided by 25%, 50%, >75% (minimum, moderate, maximum functionality). The higher the score, the great physical function the participant has.

10. Measure of Muscle Power [Up to one year]

    The Muscle Research Council Muscle Scale will be used to determine actual muscle power generation vs the anticipated power generation prior to discharge. Total score: 0 - 5, 5 is normal muscle function. Data are presented as units on a scale.

11. Fall Risk [Up to one year]

    Participant fall risk will be determined prior to discharge using the Berg Balance Scale to assess impairment of balance function through the completion of several functional tasks. The data are presented as units on a scale. The higher the number the lower the fall risk.

12. Assessment of Participant Mobility [Up to one year]

    The ICU Mobility Scale ranks a participant's mobility on a scale of 0-32, were a score of zero is a completely non-mobile individual and a score of 32 is a fully ambulatory individual. Data will be collected at the time of discharge. The data are presented as units on a scale.

13. Independent Ambulation [Up to one year]

    The number of hospital days required for the participant to regain independent ambulation (the ability to walk 5 meters unassisted) with be measured and presented as total days.

14. Mid-leg Muscle Circumference [Up to one year]

    Mid-leg muscle circumference will be measure using a metric tape measure at hospital admission and again just prior to discharge. Data will be presented as the change in muscle circumference (cm) over time.

15. Number of Patients Discharged From Hospital to Home [Up to one year]

    The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.

16. Number of Patients Discharged From Hospital to Skilled Nursing Facility [Up to one year]

    The number of participants discharged to a skilled nursing home will be counted and presented as a percentage of the total participants in that arm.

17. Number of Patients Discharged From Hospital to a Long Term Care Facility [Up to one year]

    The number of participants discharged to a long term care facility will be counted and presented as a percentage of the total participants in that arm.

18. Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility [Up to one year]

    The number of participants discharged to am acute rehabilitation facility will be counted and presented as a percentage of the total participants in that arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Admission to Trauma ICU

1. Trauma Patients requiring physical therapy (including severe traumatic brain injury or polytrauma without extremity fractures or unstable thoracic or lumbar spine fracture

2. Burn patients requiring physical therapy

3. GI surgery patients requiring physical therapy

4. Necrotizing fasciitis patient requiring physical therapy

Exclusion Criteria:

Patients with the following conditions:

1. Non-weight bearing on lower extremities

2. Untreated DVT

3. Active hemorrhage

4. Leg length >102cm or <72cm

5. Weight >135kg

6. Systolic BP > 20mmHg sustained for 10min

7. Heart rate >20bpm outside goal for more than 20min

8. Intracranial pressure (ICP) >20mmHg sustained for 10min if applicable,

9. Temperature >38.2C

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• Lisa J. Fryman

Investigators

• Principal Investigator: Andrew Bernard, MD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisa J. Fryman, Nursing Director Trauma/Surgical Services, University of Kentucky
• ClinicalTrials.gov Identifier: NCT02615990
• Other Study ID Numbers: Erigo 15-0519
• First Posted: Nov 26, 2015
• Last Update Posted: May 25, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Period Title: Overall Study
STARTED	1	1
COMPLETED	0	0
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy	Total
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.	Total of all reporting groups
Overall Participants	1	1	2
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	1 100%	1 100%	2 100%
Sex: Female, Male (Count of Participants)
Female	1 100%	0 0%	1 50%
Male	0 0%	1 100%	1 50%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	1 100%	1 100%	2 100%

Outcome Measures

1. Primary Outcome

Title	Orthostatic Tolerance During Verticalization
Description	Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from lying down to standing. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial verticalization after injury and at each treatment session there after until they achieve ambulation (the ability to move without assistance). Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from lying to standing.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

2. Primary Outcome

Title	Orthostatic Tolerance During Ambulation
Description	Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from standing to full ambulation. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial unassisted standing and then during each treatment session there after until discharge. Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from standing to full ambulation.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

3. Secondary Outcome

Title	ICU Length of Stay
Description	The duration of stay in the Trauma ICU will be measured and compared between groups. Data will be presented as mean number of days in the ICU.
Time Frame	Up to three months

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

4. Secondary Outcome

Title	Hospital Length of Stay
Description	The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

5. Secondary Outcome

Title	Incidence of Pneumonia While Hospitalized
Description	Incidence of pneumonia while hospitalized will be determined by clinical symptoms to include temperature >100.8 degrees F, WBC>12,000 WBC/mm3 , PaO2/Fio2 ratio < 300 mmHg, positive respiratory culture for organisms and chest x-ray indicative of pneumonia. Total incidence will be compared between groups and presented as a total count of pneumonia diagnoses per group.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

6. Secondary Outcome

Title	Incidence of Urinary Tract Infections While Hospitalized
Description	Incidence of urinary tract infection during hospitalization will be determined by clinical symptoms to include temperature of > 100.8 degrees F, WBC> 12000 WBC/MM3, patient complaints of pain, positive urine culture. Total incidence will be compared between groups and presented as a total count of urinary tract infection diagnoses per group.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

7. Secondary Outcome

Title	Incidence of Deep Vein Thrombosis (DVT)
Description	Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

8. Secondary Outcome

Title	Incidence of Pressure Ulcers
Description	Incidence of pressure ulcers determined by physical observation. Total incidence will be compared between groups and presented as a total count of pressure ulcer diagnoses per group.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

9. Secondary Outcome

Title	Incidence of Physical Instability
Description	Incidence of physical instability with be calculated as the number of falls per participant while hospitalized. Data will be presented as the number of falls per participant per group.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

10. Secondary Outcome

Title	Incidence of Catheter Disruption
Description	Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

11. Secondary Outcome

Title	Measure of Physical Capacity
Description	Kansas University Hospital Physical Therapy Acute Care Functional Outcome Tool will be utilized to assess the participant's overall physical function prior to discharge. . Total score: 0 - 32, usually divided by 25%, 50%, >75% (minimum, moderate, maximum functionality). The higher the score, the great physical function the participant has.
Time Frame	At discharge (up to 1 year)

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

12. Secondary Outcome

Title	Measure of Muscle Power
Description	The Muscle Research Council Muscle Scale will be used to determine actual muscle power generation vs the anticipated power generation prior to discharge. Total score: 0 - 5, 5 is normal muscle function. Data are presented as units on a scale.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

13. Secondary Outcome

Title	Fall Risk
Description	Participant fall risk will be determined prior to discharge using the Berg Balance Scale to assess impairment of balance function through the completion of several functional tasks. The data are presented as units on a scale. The higher the number the lower the fall risk.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

14. Secondary Outcome

Title	Assessment of Participant Mobility
Description	The ICU Mobility Scale ranks a participant's mobility on a scale of 0-32, were a score of zero is a completely non-mobile individual and a score of 32 is a fully ambulatory individual. Data will be collected at the time of discharge. The data are presented as units on a scale.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

15. Secondary Outcome

Title	Independent Ambulation
Description	The number of hospital days required for the participant to regain independent ambulation (the ability to walk 5 meters unassisted) with be measured and presented as total days.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

16. Secondary Outcome

Title	Mid-leg Muscle Circumference
Description	Mid-leg muscle circumference will be measure using a metric tape measure at hospital admission and again just prior to discharge. Data will be presented as the change in muscle circumference (cm) over time.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

17. Secondary Outcome

Title	Number of Patients Discharged From Hospital to Home
Description	The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

18. Secondary Outcome

Title	Number of Patients Discharged From Hospital to Skilled Nursing Facility
Description	The number of participants discharged to a skilled nursing home will be counted and presented as a percentage of the total participants in that arm.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

19. Secondary Outcome

Title	Number of Patients Discharged From Hospital to a Long Term Care Facility
Description	The number of participants discharged to a long term care facility will be counted and presented as a percentage of the total participants in that arm.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

20. Secondary Outcome

Title	Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility
Description	The number of participants discharged to am acute rehabilitation facility will be counted and presented as a percentage of the total participants in that arm.
Time Frame	Up to one year

Outcome Measure Data

Analysis Population Description

ERIGO Pro manufacture requested the device be returned before any subject completed the protocol

Arm/Group Title	Erigo Pro Plus Standard Physical Therapy	Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading	Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
Measure Participants	0	0

Adverse Events

Time Frame	Adverse events were collected during hospitalization, up to one year.
Arm/Group Title	Erigo Pro Plus Standard Physical Therapy		Standard Physical Therapy
Arm/Group Description	The Erigo device therapy is a combination of tilt table with robotic stepper device allowing for cyclic leg loading. It also includes Functional Electrical Stimulation to optimize active neuromuscular stimulation. It will be used once a day to replace one of the standard PT therapies. The exercise mimics walking beyond what regular range of motion provides. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Erigo Pro: Verticalization table with two integrated robotic devices for leg movement and cyclic loading		Patients will have 3 standard Physcial Therapy session. Patients will have 2 additional PT therapies 20 minutes of standard range of motion movements. Standard Physical Therapy: Patients receive standard physical therapy.
All Cause Mortality
	Erigo Pro Plus Standard Physical Therapy		Standard Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	Erigo Pro Plus Standard Physical Therapy		Standard Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Erigo Pro Plus Standard Physical Therapy		Standard Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)

Limitations/Caveats

Study was terminated by the device manufacturer prior to any subject completing the intervention

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.